MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS

Dc-defibrillator, Low-energy, (including Paddles)

MARQUETTE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Pediatric Defibrillation/pacing Pads.

Pre-market Notification Details

Device IDK911662
510k NumberK911662
Device Name:MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee,  WI  53223
ContactSandra Schick
CorrespondentSandra Schick
MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee,  WI  53223
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-12
Decision Date1991-10-10

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